Ignite Creation Date:
2024-07-17 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478290
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-13
Brief Title:
Pilot Assessment of the Safety of a Combination of Curcumin Omega-3 and Vitamin D Supplements in ACPA Individuals
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
Official Title:
Pilot Assessment of the Safety of a Combination of Curcumin Omega-3 and Vitamin D Supplements PASCOD in ACPA Individuals
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PASCOD3
Brief Summary:
The goal of this clinical trial is to determine if the level of Anti-cyclic citrullinated peptide antibody ACPA is altered after taking curcumin omega-3 and vitamin D supplements COD for 3 months It will also determine the safety and tolerability of COD in the study population This trial aims to answer the following questions Does COD consumption lower the level of ACPA in the study participants What side effects will participants have after taking COD This pilot study will have an open label pre-post design and study participants will know that they are using each of the three supplements Participants will Take the combination of supplements following an evening meal for 84 consecutive days Visit the clinicstudy team twice during the study duration on days 0 and 84 for checkups and tests Keep a diary of study treatment consumption
Detailed Description:
Rheumatoid Arthritis RA is a prevalent autoimmune disease Curcumin formulations are recognized for their potent anti-inflammatory effects mainly targeting NF-kB signaling Supplementation with Acumin has shown significant benefits for RA patients including pain relief reduced morning stiffness and improved joint function alongside decreases in inflammatory markers and autoantibody levels In murine arthritis models a bioavailable curcumin form combined with a diet rich in vitamin D and omega-3 notably altered disease progression Therefore a pilot trial is set for anti-cyclic citrullinated peptide antibody APCA individuals without RA The primary objective of this study will determine if the level of ACPA is altered after taking curcumin omega-3 and vitamin D COD for 3 months The secondary objective is to determine the safety and tolerability of COD in the study population Exploratory outcomes will include assessment of joint symptoms blood biochemistry and hematology This study will enroll 50 ACPA individuals without RA aiming for an equal distribution of male and female participants Participants identified as ACPA from the RA Auto-antibody Detection study RAAD will undergo eligibility screening The study will involve open-label administration of ACUMIN Turmeric Complex 500 mg Omega-3 900 mg and Vitamin D3 2500 IU once daily for 84 consecutive days Joint examinations will be conducted by a study physician and blood specimens will be collected by certified phlebotomists at designated sites Trained personnel will handle questionnaire surveys anthropometrics follow-ups and coordinating visits Data will be recorded on paper-based CRFs and entered into the secure REDCap database The trial will take place at Health Sciences Centre MS7 in Winnipeg for urban participants and in First Nation communities with established research agreements with the team Norway House First Nation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None